Real-time-aging Validation - ISO / ASTM Standard - Class 111 Orthopedic Implant

mpfizer

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#1
Hi,

Can someone please advise on the standard ISO / ASTM to be followed for Real Time Aging Validation for a class 111 orthopedic implant .

Thanks

Michelle
 
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planB

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#2
Michelle,


I guess you are talking about the real-time aging validation of the sterile barrier system (SBS) of your device? If yes, then ISO 11607-1:2006, section 6.4 is your reference. You would then perform this study under the storage condition you have defined in your labelling. Typically, you take samples for package /seal integrity testing at various time points until you reach your labelled shelf life in order to detect any aging trends of your SBS over time. And typically, you would perform the very same package/seal integrity tests you had already defined in your accelerated aging protocol.


HTH,


Gerhard
 
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